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WHAT IS AN ORPHAN PRODUCT ?

An orphan product is developed for the treatment of a rare medical condition. Per the European patient advocacy group, EURORDIS, orphan products are called ”  …. “orphans” because the pharmaceutical industry has little interest under normal market conditions in developing and marketing drugs intended for only a small number of patients suffering from very rare conditions.”

In many countries, assigning of an “orphan status” to a disease and/or drug is public policy enforced with legislation and regulations. Usually, there are financial incentives, such as “exclusivity” periods. Please reference the comparison chart identifying worldwide policies on orphan drugs at the Orphanet Portal.

Per the FDA Office of Orphan Products Development (OOPD) :

Orphan “ …… products (drugs, biologics, devices, or medical foods) demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions …. OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases …..”.

Per the FDA, a rare disease/disorder is defined as affecting “fewer than 200,000 people in the US, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug”.

The US Orphan Drug Act is passed in January 1983. The US Rare Diseases Act is signed into law in 2002. Please see this Section of the FDA website for further information.

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